MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CA19-9 ASSAY; SYSTEM, TEST, CA19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer observed discordant elevated patient results with advia centaur xp ca19-9, lot 527 compared to lower results obtained on an alternate test method.The interpretation of results section of the advia centaur ca 19-9 instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Event or Problem Description
The customer reports observation of discordant patient results with advia centaur xp ca19-9, lot 527.Elevated initial results on 2 patient samples were obtained with advia centaur xp ca19-9, lot 527.The results were greater than the upper limit of normal (uln) of 35 u/ml and were not reported to physician(s).The same samples were retested on an alternate method and the results were lower (less than the method cutoff of 37 u/ml), in agreement with clinical pictures of the patients and reported to physicians as correct.There are no allegations of patient intervention or adverse health consequences due to the discordant ca19-9 results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00337 initial report with the fda on 03-jan-2024.Siemens investigated an outside the united states (ous) customer observation of discordant elevated results for 2 patient samples tested with advia centaur xp ca19-9, lot 527 compared to lower results obtained on an alternate test method.Because there is no indication of a cancer diagnosis with these 2 patients the customer believed the alternate test method results, which are within the normal range, are correct and were reported.The customer was not able to provide the patient's medical status, other than the testing was for physical examination and a pelvic cyst with sample 2, or a list of medications/supplements the patient was taking.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges and no issues were reported with other patient samples.The expected values section of the advia centaur ca 19-9 instructions for use (ifu) indicates 3.7% of samples from normal patients recovered >37 u/ml so a certain number of elevated results from normal patients can be expected for this assay.The limitations section of the ifu: states: "note do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient¿s clinical evaluation." the ifu also states: "warning the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values." the concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Based on the available information, the cause of the discordant result cannot be determined but siemens cannot rule out a sample issue or normal assay performance.The customer is operational.In section h6, the investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR CA19-9 ASSAY
• Common Device Name: SYSTEM, TEST, CA19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 18437471
• Report Number: 1219913-2024-00337
• Device Sequence Number: 15212174
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: 00630414574028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 50188527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown